NCT04311762Active, not recruitingPhase 1
Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer
Source: ClinicalTrials.gov · Last updated 31 Oct 2025
Brief summary (registry, in English)
The goal of the study is to identify the maximum tolerated dose of endobronchial ultrasound-guided transbronchial injection (EBUS-TBNI) of cisplatin for Stage IV lung cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 14 Mar 2020
- Start date
- 1 Feb 2020
- Primary completion date
- 1 Mar 2029
- Lead sponsor
- University of Vermont
- Diseases
- Lung cancer
- NCT number
- NCT04311762
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 16
- From 1 Feb 2020 to the primary completion date, 1 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of an investigational agent in prior 30 days
- Treatment with cytotoxic chemotherapy within the past 30 days
- Prior (within the last 12 months) or ongoing radiation treatment to the study NSCLC
Other illness
- Allergy to cisplatin or its derivatives
Other
- Pregnancy/lactation
- Patient not appropriate for the research study based on physician discretion
Who the study is looking for
- Age 18 years or above
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Have known or suspected metastatic NSCLC at time of enrollment (including patients who progress on initial therapy or are found to have metastatic disease during therapy and are not excluded based on 8.2 below).
- Ability and willingness to provide informed consent
- A CT scan of the chest (with or without contrast) within the prior 3 months.
- The presence of an EBUS accessible target site. These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS
- Patients must have adequate organ and marrow function as defined below:
- Leukocytes ≥3,000/mcL
- Platelets ≥100,000/mcL
- Total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ institutional ULN
- Glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2 via CKD EPI)
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Vermont Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.